Evolução de materiais de envase para

fluidos críticos da indústria farmacêutica

De garrafas de vidro à Biotecnologia

Encontro Técnico ABRASP

Indaiatuba - Brazil Outubro 23-24, 2018

Diego Morais

Sales, Marketing and Product Manager

RENOLIT Medical

RENOLIT Chile SpA

reliable|highly valued|cooperative|open-minded| innovative

Perfil da Empresa

O Grupo RENOLIT , fundado em 1946, pós segunda guerra na Alemanha, é um líder internacional na manufatura de

filmes plásticos de alta Qualidade, utilizados em diversas aplicações técnicas.

Somos uma das 20 maiores empresas familiares alemãs, de capital 100% privado, contamos com mais de 4800

empregados, 25 fabricas pelo mundo e 18 escritórios comerciais.

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential2

reliable|highly valued|cooperative|open-minded| innovative

Company Structure | Production Sites

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential3

RENOLIT

COMPOSITES

RENOLIT

CONTACT

RENOLIT

DESIGN

RENOLIT

EXTERIOR

RENOLIT

EXTRUSION

RENOLIT

MEDICALRENOLITPROFESSION

RENOLITWATERPROOFING

RENOLIT Belgium N.V., Oudenaarde (BE)

RENOLIT SE, Frankenthal (DE)

RENOLIT SE, Munich (DE)

RENOLIT SE, Thansau (DE)

RENOLIT Cramlington Ltd., Cramlington (GB)

RENOLIT Czech s.r.o., Most (CZ)

RENOLIT GOR S.p.A., Buriasco (IT)

RENOLIT South Africa Pty. Ltd., Sasolburg (ZA)

RENOLIT Iberica, S.A., Sant Celoni (ES)

RENOLIT Ondex S.A.S., Chevigny (FR)

American RENOLIT Corporation, La Porte (US)

American RENOLIT Corporation LA, Commerce (US)

Changzhou Wood-Stock Co., Ltd., Changzhou (CN)

RENOLIT Guangzhou Ltd., Guangzhou (CN)

RENOLIT Nederland B.V., Enkhuizen (NL)

RENOLIT SE, Waldkraiburg (DE)

RENOLIT SE, Worms (DE)

RENOLIT Hispania, S.A., Villatuerta (ES)

Beijing Wood-Stock Co., Ltd., Beijing (CN)

Beijing Austar Hansen Packaging Techn. Ltd., Beijing (CN)

RENOLIT Milano S.r.L., Peschiera Borromeo (IT)

Brightwood PharmMed Consumable Ltd., Beijing (CN)

Beijing Austar PMC Co., Ltd., Beijing (CN)

Senxing Pharmaceutical Consumable Ltd., Beijing (CN)

APPL GOR PLASTICS INDIA PVT. LTD., Pune (IN)

reliable|highly valued|cooperative|open-minded| innovative Company Presentation | April 20174 |

RENOLIT the companyWorldwide Locations

RENOLIT Ondex S.A.S.

RENOLIT Polska Sp. z o.o.

RENOLIT Portugal Ltda.

RENOLIT SE, Frankenthal

RENOLIT SE, Munich

RENOLIT SE, Thansau

RENOLIT SE, Waldkraiburg

RENOLIT SE, Worms

RENOLIT Tábor s.r.o.

OOO RENOLIT-Rus

TOB RENOLIT Sales

Asia

APPL GOR PLASTICS INDIA PVT. LTD.

Changzhou Wood-Stock Co., Ltd.

RENOLIT Beijing Medical (2 Locations)

RENOLIT Guangzhou Ltd.

RENOLIT Hong Kong Ltd.

RENOLIT India Private Limited

North America

American RENOLIT Corporation LA

American RENOLIT Corporation, La Porte

RENOLIT México S.A. de C.V.

South America

RENOLIT Chile SpA.

Europe

RENOLIT Belgium N.V.

RENOLIT Benelux B.V.

RENOLIT Cramlington Limited

RENOLIT France SASU

RENOLIT GOR S.p.A.

RENOLIT Hispania, S.A.

RENOLIT Hungary LLC

RENOLIT Ibérica, S.A.

RENOLIT Istanbul Plastik

San ve Tic Ltd Sti

RENOLIT Italia S.r.l.

RENOLIT Milano S.r.l.

RENOLIT Nederland B.V.

RENOLIT Nordic A/S

reliable|highly valued|cooperative|open-minded| innovative

Evolução da Indústria Plástica e Farmacêutica

Melhorias da indústria

MercadoProcessos

Regulação

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential5

reliable|highly valued|cooperative|open-minded| innovative

Evolução dos materiais de envase de fluidos críticos Industria Farmacêutica

Soro

Nutrição Parenteral

Dialise

Sangue

Biotecnologia

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential6

reliable|highly valued|cooperative|open-minded| innovative

Evolução dos materiais de envase de fluidos críticos Industria Farmacêutica

Soro

Nutrição Parenteral

Dialise

Sangue

Biotecnologia

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential7

reliable|highly valued|cooperative|open-minded| innovative

Soro : Do Sistema Aberto para o Sistema Fechado

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential8

Custo

Praticidade

LogísticaSegurança

reliable|highly valued|cooperative|open-minded| innovative

Medicamentos – Vantagens da Co-extrusão

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential9

reliable|highly valued|cooperative|open-minded| innovative

PP e outros materiais– Estruturas multi-camadas (Co-extrusão)

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential10

PP – Escudo Termico / proteção

PP -- Flexibilidade

PP – Camada Selante / Contato com a Solucao

PP – Escudo Términco

EVOH – Barreira ao O2 - Flexibilidade

PP – Camada Selante / Contato com a Solução

Adesivo

Adesivo

MEDICAMENTOS

reliable|highly valued|cooperative|open-minded| innovative

Evolução dos materiais de envase de fluidos críticos Industria Farmacêutica

Soro

Nutrição Parenteral

Dialise

Sangue

Biotecnologia

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential11

reliable|highly valued|cooperative|open-minded| innovative

Nutrição Parenteral

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential12

Principais Desafios:

Incompatibilidade dos diferentes

componentes: Amino ácidos, Glucose e

lipídeos (exposição estendida)

Grande sensibilidade ao O2

Sensibilidade à UV.

= Vida útil Muito Curta

reliable|highly valued|cooperative|open-minded| innovative

Nutrição Parenteral

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential13

150 KM

350 KM

600 KM

+ EVOH (Barreira a o2)

+ SEGREDO (Barreira a UV)

reliable|highly valued|cooperative|open-minded| innovative

Nutrição Parenteral – Industrialização Massiva – Bolsas Multicompartimento

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential14

Vida útil extendida (aprox. 6 meses)

reliable|highly valued|cooperative|open-minded| innovative

Evolução dos materiais de envase de fluidos críticos Industria Farmacêutica

Soro

Nutrição Parenteral

Dialise

Sangue

Biotecnologia

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential15

reliable|highly valued|cooperative|open-minded| innovative

Dialise – Bicarbonato de Sódio (Outras aplicacoes de Multicompartimentos)

Desafios:

Esterilização

Alcalinidade

Sensibilidade a o2

Floculação

Incompatibilidade

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential16

reliable|highly valued|cooperative|open-minded| innovative

Evolução dos materiais de envase de fluidos críticos Industria Farmacêutica

Soro

Nutrição Parenteral

Dialise

Sangue

Biotecnologia

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential17

reliable|highly valued|cooperative|open-minded| innovative

Bolsas de Sangue em Geral : PVC

Principal desafio do Sangue é a necessidade de permeabilidade ao O2.

Portanto, nesta indústria, impera o PVC.

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential18

reliable|highly valued|cooperative|open-minded| innovative

Diferentes Plastificantes para diferentes funções.

DEHP based PVC for Whole blood, Red cell, Plasma O2 permeability +/- 590cc/m2.day.bar

TOTM based PVC for buffycoat bag (platelet ) O2 permeability +/- 800cc/m2.day.bar

Citrate bag for platelet pool bag (6x concentration) O2 permeability +/- 2100cc/m2.day.bar

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential19

reliable|highly valued|cooperative|open-minded| innovative

Hemoderivados – Plasma Albumina

Grandes Desafios:

Altíssima sensibilidade à O2.

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential20

reliable|highly valued|cooperative|open-minded| innovative

Lamination - Process

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential21

OTR (23 Celsius / 0% RH) Unit: cm3/m2/ day/bar)

PVC tradicional (DEHP) 1100

Filme Renogard “low barrier” 0.5

Filme Renogard “Ultra High

Barrier” 0.1

reliable|highly valued|cooperative|open-minded| innovative

Evolução dos materiais de envase de fluidos críticos Industria Farmacêutica

Soro

Nutrição Parenteral

Dialise

Sangue

Biotecnologia

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential22

reliable|highly valued|cooperative|open-minded| innovative

Biotecnologia – Utilização de maquinaria Biológica para beneficio humano.

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential23

reliable|highly valued|cooperative|open-minded| innovative RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential24

Biotecnologia – Utilização de maquinaria Biológica para beneficio humano.

RENOLIT Medical | Sales Training Presentation: March 2013 – Business Confidential25

Diego.Morais@renolit.com